Verified Job
Lab Technician / Pharmacist
Clinical Pharmacology Lead (Jaipur)
Lab Technician / Pharmacist
#767547
Remote / WFH
Sun Pharma Advanced Research Company
Job Description
We are seeking a strategic and scientifically driven Clinical Pharmacology Lead to support the development of innovative therapies in Dermatology (topical products), Immunology and Oncology (biologics). This role will be instrumental in designing and executing clinical pharmacology and model informed drug development (MIDD) strategies across early-phase development programs, with a robust emphasis on global clinical development and regulatory engagement.
Responsibilities
- Lead clinical pharmacology strategy for dermatology and oncology programs from pre-IND through early clinical development and beyond.
- Collaborate with cross-functional teams including discovery, translational sciences, clinical operations, regulatory affairs, and biostatistics.
- Design and oversee Phase I and early Phase II studies including FIH, SAD/MAD, bioavailability, and PK/PD studies, maximum use studies for topical formulations tailored to topical compounds and biologics and ADCs.
- Integrate clinical pharmacology data and utilize appropriate modeling and simulation approaches (e.g., PK/PD, PBPK, PopPK, ER response etc) to support dose selection, formulation optimization, and study design.
- Analyze and interpret pharmacokinetic and pharmacodynamic data to inform clinical decisions and development milestones.
- Author and review clinical pharmacology sections of regulatory documents (INDs, IBs, CTDs, briefing books) and scientific publications.
- Represent clinical pharmacology in global regulatory interactions (FDA, EMA, PMDA) and contribute to submission strategies.
- Oversight of bioanalysis of large and small molecules including method development and validation for pharmacokinetic assessments and oversight of sample management in clinical studies.
- Stay current with advances in topical drug delivery systems in dermatology and biologic therapies in oncology.
- Contribute to biomarker strategy and translational approaches to enhance understanding of drug mechanism and patient response.
Qualifications
- PhD, PharmD, or MD in Clinical Pharmacology, Pharmaceutical Sciences, or related field
Required Skills
- Minimum of 10 years of industry experience in clinical pharmacology, with demonstrated expertise in supporting clinical development of NMEs for dermatology and/or oncology.
- Strong understanding of clinical PK analysis, PK/PD, PK modeling and simulations including pop PK, PBPK, QSP etc, biostatistics, and translational science with NCEs, NBEs and ADCs.
- Basic understanding of bioanalytical techniques, including method development and validation for pharmacokinetic assessments.
- Familiarity with radiolabel studies and their application in absorption, distribution, metabolism, and excretion (ADME) profiling.
- Proven track record in early-phase clinical development and global regulatory submissions.
- Excellent knowledge of global regulatory requirements for Clinical Pharmacology data.
Responsibilities
- Lead clinical pharmacology strategy for dermatology and oncology programs from pre-IND through early clinical development and beyond.
- Collaborate with cross-functional teams including discovery, translational sciences, clinical operations, regulatory affairs, and biostatistics.
- Design and oversee Phase I and early Phase II studies including FIH, SAD/MAD, bioavailability, and PK/PD studies, maximum use studies for topical formulations tailored to topical compounds and biologics and ADCs.
- Integrate clinical pharmacology data and utilize appropriate modeling and simulation approaches (e.g., PK/PD, PBPK, PopPK, ER response etc) to support dose selection, formulation optimization, and study design.
- Analyze and interpret pharmacokinetic and pharmacodynamic data to inform clinical decisions and development milestones.
- Author and review clinical pharmacology sections of regulatory documents (INDs, IBs, CTDs, briefing books) and scientific publications.
- Represent clinical pharmacology in global regulatory interactions (FDA, EMA, PMDA) and contribute to submission strategies.
- Oversight of bioanalysis of large and small molecules including method development and validation for pharmacokinetic assessments and oversight of sample management in clinical studies.
- Stay current with advances in topical drug delivery systems in dermatology and biologic therapies in oncology.
- Contribute to biomarker strategy and translational approaches to enhance understanding of drug mechanism and patient response.
Qualifications
- PhD, PharmD, or MD in Clinical Pharmacology, Pharmaceutical Sciences, or related field
Required Skills
- Minimum of 10 years of industry experience in clinical pharmacology, with demonstrated expertise in supporting clinical development of NMEs for dermatology and/or oncology.
- Strong understanding of clinical PK analysis, PK/PD, PK modeling and simulations including pop PK, PBPK, QSP etc, biostatistics, and translational science with NCEs, NBEs and ADCs.
- Basic understanding of bioanalytical techniques, including method development and validation for pharmacokinetic assessments.
- Familiarity with radiolabel studies and their application in absorption, distribution, metabolism, and excretion (ADME) profiling.
- Proven track record in early-phase clinical development and global regulatory submissions.
- Excellent knowledge of global regulatory requirements for Clinical Pharmacology data.
